Vaginal speculum

ABSTRACT

The invention relates to a vaginal speculum comprising two spoon blades, which are intended for insertion into the vagina, and which are elongated and are located along side and opposite one another;—are mutually hinging in a clamped plane and through the longitudinal direction between a closed and open position; in which a handle is provided with operating means, in which the speculum is constructed in modular fashion with a first and a second module, the first module comprising the spoon blades, and the second module comprising the handle, and in which—the speculum further comprises transmission means that connect the operating means to the spoon blades, for opening and/or closing the spoon blades by means of the operating means; and in which—the speculum comprises connecting means, for connecting the first and second module together is a disconnectable manner. The invention also relates to an assembly comprising a second module for a vaginal speculum and two or more first modules for a vaginal speculum, the two or more first modules comprising at least two first modules with mutually differing dimensions.

This application is a national stage filing under 35 U.S.C. 371 ofInternational Application PCT/NL2003/000738, filed on Oct. 29, 2003,which claims priority from NL Application No: 1021773, filed on Oct. 29,2002. The entire teachings of the referenced Applications areincorporated herein by reference. International ApplicationPCT/NL2003/000738 was published under PCT Article 21(2) in English.

The present invention relates to a vaginal speculum comprising:

-   -   two spoon blades, which are intended for introduction into the        vagina, which are elongated and are located alongside and        opposite one another, and which are mutually hinging about a        hinge with a hinge axis running in the widthwise direction of        the spoon blades;    -   a handle module provided with operating means and a handle, the        spoon blades being fixed detachably on the handle module.

Such a speculum is known from U.S. Pat. No. 3,769,980. This publicationrelates to a speculum in combination with a curette. The speculum iscomposed of a base part. The base part comprises two mutually hingingarms, which are each provided with a spoon blade on the distal end. Saidspoon blades can each be disconnected individually from the respectivearm. The spoon blades here form two parts that are separate from eachother. The idea here is to replace the spoon blades after use.

WO 01/47406 discloses a speculum in which the handle is connected in adisconnectable manner to one of the two spoon blades. This means thatwhen the speculum has been introduced into the vagina the handle isalways connected to the spoon blades. A disadvantage of this is that theuse of other examination means for internal examination, such as, forexample, instrumentarium that is used for examination or treatment on orin the uterus and vagina, is restricted because of the space taken up bythe handle.

It is true that detachable mirror or lighting means can be attached tothe handle, but the possibilities or impossibilities for doing this arerestricted through the specific embodiment of the handle.

The specula known from the prior art in general attempt to avoid theabovementioned disadvantage either by integrating lighting means orother examination means in the specific embodiment of the handle or byusing the space that arises between the top and bottom part of thehandle on opening of the speculum. In the design of a speculum the aimis therefore in general to keep this space as large as possible. It isalso known from the prior art, namely from WO 98/25512, to place overthe handle of a conventional speculum an attachment accessory, whichaccessory can have a light source.

Another disadvantage of the direct connection between the handle and oneof the two spoon blades is that during the internal examination thehandle is projecting all the time from the woman's body, which willgenerally be an unpleasant experience for her.

Yet a further disadvantage is that in the case of the conventionalspecula the entire speculum is generally either thrown away after use oris sterilized after use for reuse. Sterilization of the entire speculumhas the disadvantage that the handle, which during use is generally muchless heavily soiled than the part to be introduced into the vagina, iscleaned much more thoroughly than is strictly necessary. Thedisadvantage of throwing away the entire speculum is that a relativelylarge amount of material is wasted.

The object of the invention is to provide an improved speculum thatpreferably entirely, but at least partially, overcomes theabovementioned disadvantages, is more user-friendly and provides greaterexamination freedom for the doctor, or for the woman if it is a case ofself-inspection.

This object is achieved according to the invention in the case of aspeculum of the type indicated at the beginning by the fact that thespeculum is constructed in modular fashion with the handle module and aspoon blade module;

by the fact that the spoon blades and the hinge are provided on thespoon blade module;

by the fact that the speculum further comprises:

-   -   connecting means for connecting together in a disconnectable        manner the handle module and the spoon blade module; and    -   locking means for locking the spoon blades in an open position;        and        by the fact that the locking means are provided on the spoon        blade module and comprise locking elements that are designed to        hold the spoon blades locked in the open state in the vagina        when the handle module of the spoon blade module is disconnected        after the spoon blades have been introduced into the vagina and        are in the open state.

The modular speculum according to the invention provides a number ofconsiderable advantages. The greatest advantage is that after thedisconnection of the handle module when the spoon blades have beenintroduced and are in the open state there is much more freedom tomaneuver for examination or other operations. In view of the simplemechanical connection between handle module and spoon blademodule—explained in greater detail in the description of the figures—itwould also be possible to connect to the spoon blade module modulesother than the handle module, such as, for example, a module with aspecial fiber optic or modules that facilitate the instrumentation, suchas, for example, a part of an instrument, camera or endoscope as an aid.

Another advantage is that if the handle module is disconnected duringthe examination the possibility of contamination of it is prevented asfar as possible.

Yet another advantage is that one handle module can be used incombination with various spoon blade modules. The relatively simpleembodiment of the spoon blade module—see further in thedescription—means that it is even possible to choose to throw away thespoon blade module after use.

According to a further advantageous embodiment of the invention, thespoon blade module is provided externally with at least one surface thattapers relative to the longitudinal direction of the spoon blades in thedistal direction of the latter, upon which surface, when the speculumhas been introduced into the vagina, the sphincter vaginae can act insuch a way that a force acting in the distal direction is exerted uponthe speculum, which force holds the speculum in the vagina while thespoon blades are not yet spread.

The muscle tissue situated at the mouth of the vagina comprises inparticular the musculus sphincter ani externus and the left-hand andright-hand parts of the musculus bulbocavernosus. The musculusbulbocavernosus together with the musculus sphincter ani externus formsa ring of muscle tissue surrounding the mouth of the vagina, furtherreferred to as the sphincter vaginae. If the spoon blade module of thevaginal speculum according to the invention is of suitable size andshape, it is found that this ring of muscle tissue is capable of fixingthis spoon blade module in the mouth of the vagina.

The specula used in practice have an assembly of spoon blades providedwith external surfaces which, viewed in the longitudinal direction ofthe speculum, taper in the proximal direction and in this way form anapplication surface for a force for expelling the speculum, which force,as a result of the elastic properties of the muscle tissue in thevagina, is exerted upon a speculum that has been introduced.

The fact that the spoon blade module can be designed in many differentways for achieving the fixing effect aimed at according to the inventionwill be clear to a person skilled in the art, given the anatomy of thehuman body.

In order to simplify the manufacture of the spoon blade module, it isadvantageous according to the invention, if the hinge comprises a stripof material with a flexibility that permits hinging. This makes itpossible to have the spoon blade module made of one part—leaving asidethe transmission means—for example by means of two-component injectionmolding, instead of separate spoon blades, which are connected, forexample, by means of a hinge pin. This design has the advantage over adesign with a hinge pin that there is less risk of the tissue becomingtrapped between the spoon blades. Furthermore, such an embodimentreduces the production costs of the spoon blade module.

According to a further advantageous embodiment of the speculum accordingto the invention, the spoon blades are provided with protuberances onthe outside at edge parts of the spoon blades that lie opposite eachother when the spoon blades are closed. On closing of the spoon blades,said protuberances will push the wall of the vagina slightly furtheraway at that point, so that the risk of the tissue becoming trappedbetween the spoon blades is considerably reduced.

In order to prevent possible contamination of the handle module by bodyfluids, the spoon blade module of the speculum is provided with acollection channel on the underside. It has already been said above thatthrough disconnection of the handle during the examination,contamination of the spoon blade module is prevented as far as possiblefrom spreading to the handle module. The collection channel willsubstantially prevent contamination from reaching the handle when thehandle module is connected to the spoon blade module.

According to yet another advantageous embodiment of the invention, thehandle module and the spoon blade module can be attached to each otherby means of a connection consisting of slots in the end face of one ofthe two modules, on the one hand, and insertion parts on the end face ofthe other module, on the other hand, which insertion parts are insertedinto the slots. Such a mechanical connection makes connection anddisconnection of the handle module very easy and achievable with onehand. Furthermore, this means that it is relatively simple to designother modules, such as the abovementioned fiber optic module or modulesthat facilitate instrumentation, such as, for example, a part of aninstrument, camera or endoscope, in such a way that they can beconnected to the spoon blade module in a similar manner to that of theconnection of the handle module.

Owing to the simple operation mechanism on the handle module for openingand closing of the spoon blades, the easy mechanical connection anddisconnection of the handle module and the spoon blade module, and tothe exertion of a force acting upon the speculum in the distal directionwhich holds the speculum in the vagina, the speculum according to theinvention is pre-eminently suitable for self-inspection.

According to a further aspect, the invention relates to an assemblycomprising the handle module and two or more spoon blade modules. Inparticular, it is an advantage here if the two or more spoon blademodules comprise at least two modules with mutually differingdimensions.

In combination with the abovementioned simple mechanical connectionbetween spoon blade modules and handle module, in the event of a spoonblade module that is not an entirely good fit, during the internalexamination it will be relatively easy to introduce another spoon blademodule with a better fit.

This aspect of the invention, together with the abovementioned simpleproduction method of the spoon blade module, also makes it possible touse disposable spoon blades.

The present invention will be illustrated in greater detail below withreference to appended drawings, in which:

FIG. 1 shows diagrammatically the speculum in side view and partially inmid-longitudinal section, in the opened position of the spoon blades;

FIG. 2 shows diagrammatically the speculum in side view and partially inmid-longitudinal section, in the closed position of the spoon blades;

FIG. 3 shows a diagrammatic top view of the speculum, partially in crosssection, with handle module and spoon blade module connected to eachother;

FIG. 4 shows a diagrammatic top view of the speculum, partially in crosssection, with handle module and spoon blade module disconnected fromeach other;

FIG. 5 shows the spoon blade module in side view, with the bottom andtop spoon blades connected by means of a hinge pin;

FIG. 6 shows an enlarged detail of section VI from FIG. 5, with thebottom and top spoon blades connected by means of a hinged strip ofmaterial.

FIG. 1 shows the speculum according to the invention in side view,partially in cross section and with the spoon blades in an openposition. FIG. 2 shows a similar view, but with the spoon blades in aclosed position. In these figures the spoon blade module 1, with a topspoon blade 2 and a bottom spoon blade 3 and the handle module 4 areclearly distinguishable, The connection between the two modules willbecome clear from the description of FIGS. 3 and 4, but the opening andclosing of the spoon blades will be explained first.

In FIGS. 1 and 2 the following can be distinguished in the handlemodule: an operating handle 5, a gear rack 6, a release button 7 and atooth 8. These components together form the abovementioned operatingmeans of the handle module. The following can be distinguished on thespoon blade module: a long transmission rod 9, and an arm 10 fixed onthe bottom blade, which arm is hinged to the transmission rod 9. Theseparts together form the abovementioned transmission means.

When the operating handle 5 and the handgrip 12 of the handle module aresqueezed toward each other—an operation which is pre-eminently suitablefor operation with one hand—the operating handle will rotate about anaxis 13. By means of a mechanical clutch 14, this rotation will beconverted into a forward movement, in this case in the distal direction,or—better—translation of the transmission rod 9.

By way of a hinge 15, the arm 10 will move downwards and open the bottomspoon blade relative to the top spoon blade.

In the course of this operation the two spoon blades swing relative tohinge 16. In these figures the hinge is indicated as a hinge pin.

When the operating handle 5 and the handgrip 12 are squeezed together,the gear rack 6 will further move inwards toward the inside of thehandgrip, with the result that the tooth 8 further engages with the isgear rack 6—in this case therefore in the direction of the operatinghandle 5—and fixes the fully or partially open position of the spoonblades. This mechanism becomes clear through comparison of the relativepositions of the abovementioned parts in FIGS. 1 and 2 respectively.

The spoon blades are closed again by depressing the release button 7,with the result that the tooth 8 comes out of the teeth of the gear rack6, the open position of the spoon blades is no longer fixed, and thespoon blades will close.

It depends on the specific embodiment of the speculum according to theinvention whether this closure of the spoon blades occurs by itself orhas to be brought about by means of an external force. Both embodimentsare possible and in particular will depend on the exact design of thehinge between the two spoon blades. If the spoon blade module is of asuitable size and shape, when this module has been introduced into thevagina it will close by itself as a result of the elastic properties ofthe muscle tissue in the vagina. The choice is therefore whether anembodiment is selected that is such that on depression of the releasebutton 7 the spoon blades close by themselves even in a position notintroduced into the vagina. In the closed position of the spoon bladesshown in FIG. 2 the spoon blades 2 and 3 are resting substantiallyagainst each other. A slight gap can be present between the spoon blades2 and 3, in order to prevent tissue from becoming trapped between thetwo spoon blades when the latter go from an open to a closed position.

Other parts that can be distinguished in FIGS. 1 and 2 are a raised edge17 (part of and directly connected to handgrip 12) and an insertion part18, which forms part of the raised edge 17.

FIGS. 3 and 4 show a diagrammatic top view of the speculum according tothe invention in the connected position (FIG. 3) and disconnectedposition (FIG. 4) respectively of the spoon blade module and handlemodule. Apart from the known, defined parts, the following can bedistinguished on the spoon blade module in these figures: two slots 19on the end face, an opening in said slot in open communication with theside of the module 20, a part of the transmission rod 9 with a toothsystem 21, and a fixing means 22. The last two parts—tooth system andfixing means—together form the abovementioned locking elements.

The following can further be distinguished on the handle module in FIGS.3 and 4; an opening 23, a wedge-shaped projection 24 on the end of theinsertion part 18, and a bend-away part 26. The insertion part 18 isconnected to the handle in such a way that said insertion part can moveup and down elastically in the vertical direction relative to the raisededge 17.

These parts provide the mechanical connection of the two modules. Thetwo insertion parts 18 are slid into slots 19, and the insertion part 18will move elastically inwards relative to the outside wall of the slotuntil the projection goes into the opening and becomes fixed there.Pushing the insertion parts 18 inwards causes the projection 24 to bereleased again from the opening 20, and the insertion parts can bepushed out of the slots again in order to disconnect the handle from thespoon blade module again. The transmission rod 9 is part of the spoonblade module and slides into the special opening 23 on the handlemodule. Other connections are also readily conceivable, such as, forexample, a bayonet connection.

During the opening of the spoon blades the fixing means 22 acts upon thetooth system 21 of the transmission rod 9 and causes fixing of the openposition of the spoon blades. Since the transmission rod 9 with thetooth system and the fixing means 22 is part of the spoon blade module,the open position of the spoon blades remains fixed during thedisconnection and connection of the handle module. The bend-away means26 ensures that on connection to the spoon blade module the fixing means22 is bent away, with the result that the fixing function is taken overby the gear rack 6 and tooth 8 of the handle. The fixing means 22according to the invention is further designed in such a way that in adisconnected state of the handle the fixing means can also be bent awayfrom the tooth system 21 by hand. In particular, this operatingmechanism is placed in a proximal position, in order to make it easy toreach, and it can be operated with one hand. This is something of aprecautionary measure, in the sense that for this the spoon blades in aposition introduced into the vagina are also easy to close when thehandle is disconnected.

In the top view of FIGS. 3 and 4 a surface 25 that tapers in the distaldirection relative to the longitudinal direction of the spoon blades isshown. This surface ensures that a force acting in the distal directionis exerted, which force holds the speculum in the vagina. According tothe invention it is not necessary for this surface to be provided atexactly this position, or for it to have exactly this shape.

FIG. 5 shows the spoon blade module in side view with the spoon bladesin the closed position. The position of the opening 20 can be seenclearly in this figure. The shape of and the connection 27 between thetwo spoon blades can also be distinguished in this figure.

FIG. 5 further shows the position of the abovementioned protuberance 28on the edge of the top spoon blade. For the function of theseprotuberances—in the main preventing vaginal tissue from being trappedduring closure of the spoon blades—it is not necessary according to theinvention for the protuberance to be provided on the top spoon blade.

Such a protuberance can be produced relatively easily by, for example,adapting an injection mold to it.

FIG. 6, an enlarged detail of section VI from FIG. 5, shows a possiblespecific embodiment of the speculum according to the invention. In thiscase a strip of material 29 with a flexibility that permits hingingmovement is used over a part of the cross section at the position of thehinges.

The advantage is that in that case the two spoon blades form a part thatcan be manufactured in one process step, for example by means oftwo-component injection molding.

The dotted line 30 in FIG. 5 shows diagrammatically the boundary betweenthe inside and outside part of the spoon blade module. This makes itclear that the bottom spoon blade and the hinged part with the hinge aresituated entirely in the inside part. According to the invention, thisis preferable because during spreading of the spoon blades the mouth ofthe vagina, in particular the fleshy ring of muscle tissue, undergoeslittle or no stretching, which improves the user-friendliness.

As shown in FIG. 5, a ring of muscle tissue, the sphincter vaginae, issituated at the mouth of the vagina, consisting of the left-hand andright-hand part of the musculus bulbocavernosus 31 and the musculussphincter ani externus 32. The musculus bulbocavernosus has on its topside an attachment to the pubic bone 33 and on its underside isconnected to the musculus sphincter ani externus 32. The sphinctervaginae circumscribes the mouth of the vagina, and on tensing will fixthe speculum according to the invention. This tensing can occurpassively through stretching of the sphincter vaginae with the spoonblade module of the speculum and/or actively by tensing of the sphinctervaginae.

1. A vaginal speculum comprising: two spoon blades, which are intended for introduction into the vagina, which are elongated and are located alongside and opposite one another, and which are mutually hinging about a hinge with a hinge axis running in the widthwise direction of the spoon blades; a handle module provided with operating handle and a handgrip, the spoon blades being fixed detachably on the handle module, wherein the speculum is constructed in modular fashion with the handle module and a spoon blade module; wherein spoon blades and the hinge are provided on the spoon blade module; wherein the speculum further comprises: a connecting means for connecting together in a disconnectable manner the handle module and the spoon blade module; and locking means for locking the spoon blades in an open position; and transmission means for transmitting movement of the operating handle into relative swinging of the spoon blades; wherein the transmission means are provided on the spoon blade module wherein the locking means are provided on the spoon blade module and comprise locking elements that are designed to hold the spoon blades locked in the open state in the vagina when the handle module is disconnected from the spoon blade module after the spoon blades have been introduced into the vagina and are in the open state.
 2. The vaginal speculum as claimed in claim 1, in which the locking elements can be disconnected.
 3. The vaginal speculum as claimed in claim 1, in which the spoon blade module is provided externally with at least one surface that tapers relative to the longitudinal direction of the spoon blades in the distal direction of the latter, upon which surface, when the speculum has been introduced into the vagina, the sphincter vagina can act in such a way that a force acting in the distal direction is exerted upon the speculum, which force holds the speculum in the vagina.
 4. The vaginal speculum as claimed in claim 1, in which the hinge is situated in the vagina when the spoon blades have been introduced into the vagina, and in which the hinge is provided on the underside of the spoon blade module.
 5. The vaginal speculum as claimed in claim 1, in which the hinge comprises a strip of material with a flexibility that permits hinging.
 6. The vaginal speculum as claimed in claim 1, in which the spoon blades are provided with protuberances on the outside at edge parts of the spoon blades that rest against each other—or face each other—when the spoon blades are closed.
 7. The vaginal speculum as claimed in claim 1, in which the spoon blade module is provided with a collection channel on the underside.
 8. The vaginal speculum as claimed in claim 1, wherein the handle module and the spoon blade module are attached to each other by a connection consisting of slots in the end face of one of the two modules, on the one hand, and insertion parts on the end face of the other module, on the other hand, which insertion parts are inserted into the slots.
 9. An assembly comprising a vaginal speculum as claimed in claim 1, further comprising two or more spoon blade modules.
 10. The assembly as claimed in claim 9, in which the two or more spoon blade modules comprise at least two spoon blade modules with mutually differing dimensions.
 11. The assembly as claimed in claim 1, in which the transmission means comprises a transmission rod extending through the spoon blade module and adapted for translation in its longitudinal direction, in which the locking means comprise a tooth system provided on the transmission rod and fixing means acting upon the tooth system for fixing, in a disconnectable manner, the transmission rod with respect to the spoon blade module. 